SMC gives go-ahead for Pradaxa and Novartis’ CML drug Tasigna

by | 10th Jun 2008 | News

Boehringer Ingelheim says that the Scottish Medicines Consortium has accepted its oral anticoagiulant Pradaxa for routine use in the National Health Service of Scotland.

Boehringer Ingelheim says that the Scottish Medicines Consortium has accepted its oral anticoagiulant Pradaxa for routine use in the National Health Service of Scotland.

Pradaxa (dabigatran etexilate) was recently granted marketing authorisation by the European Commission for the prevention of venous thromboembolic events in adults who have undergone total hip or knee replacement surgery. It has also just received a postive recommendation from the Danish Institute for Rational Pharmacotherapy, which belongs to the Danish Medicines Agency, as a good alternative to low molecular weight heparins both with respect to efficacy and ease of use.

Boehringer said that the decisions on Pradaxa “are the first by European health technology assessment bodies and their positive outcomes are likely to be viewed favourably” by decision-makers considering the reimbursement of the drug. Pradaxa, which is currently being evaluated in stroke and to prevent heart attacks in patients with acute coronary syndrome, stole a march on Bayer’s rival experimental drug Xarelto (rivaroxaban) when the European approval came through at the end of March.

Back to Scotland and the SMC also announced that Novartis’ Tasigna (nilotinib) is accepted for use within NHS Scotland for treatment of adult patients with Philadelphia positive chronic myelogenous leukaemia, who are resistant to or intolerant of at least one prior therapy, including the Swiss firm’s Glivec (imatinib), in the early phase of the disease.

CML affects 4,000 people in the UK and 3% of them cannot take Glivec because of intolerance or because their cancer mutates and becomes resistant to the latter. Sandy Craine of CML Support UK said “we applaud the SMC for their prompt and timely approval of the use of Tasigna for patients who don’t respond to current therapies”, adding that the decision “is an important therapeutic advance for patients living in Scotland”. The drug was launched in the UK on May 15.

Faring less well at the hands of the SMC was Roche’s Avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy for treatment of patients with metastatic carcinoma of the colon or rectum. The Consortium decided that Roche “did not present a sufficiently robust economic analysis to gain acceptance”. However Abbott Laboratories got the go-ahead for Humira (adalimumab) for the treatment of chronic plaque psoriasis, with restrictions.

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